EU to review Samsung Bioepis’ Humira biosimilar

European regulators have agreed to review Samsung Bioepis' SB5, a biosimilar version of AbbVie's Humira, the world's second-best selling drug.

Humira (adalimumab) is cleared for use in the European Union to treat moderate to severe rheumatoid arthritis (RA), ankylosing spondylitis, moderate to severe plaque psoriasis, active and progressive psoriatic arthritis, moderate to severely active Crohn's disease, and moderate to severely active ulcerative colitis.

The firm says its application for SB5 includes data two head-to-head studies: a Phase I study in healthy volunteers that demonstrated pharmacokinetic bioequivalence to Humira; and a Phase III trial, in which SB5 demonstrated comparable efficacy, safety, and immunogenicity to its reference drug in patients with RA.

Twenty-four week data from the Phase III trial showed ACR20 response rate of 72.5 percent in the SB5 arm versus 72.0 percent in the adalimumab arm, while safety profiles were also comparable.

Humira, an anti-TNF monoclonal antibody, pulls in annual sales of nearly $15 billion across its range of indications for inflammatory diseases. While pricing data for Eurpoean nations should the drug be approved isn't yet available, the offering is expected to be significantly cheaper and thus has the potential to generate substantial savings for healthcare providers.

"The submission of SB5 by Samsung Bioepis reflects the joint goal of the partners to take the lead in expanding access to high-quality biologic therapies for those living with chronic inflammatory disorders," said Alpna Seth, global head of the Biosimilars Business Unit at Biogen.

"At an estimated $4 billion a year, Humira is among the EU's largest single drug expenditures, but access still remains variable in many markets. If SB5 is approved, we will have the potential to make a substantial impact by bridging this access gap for patients while supporting the sustainability of healthcare systems."

The marketing application for SB5 is the third anti-TNF biosimilar candidate to be submitted to the European Medicines Agency by Samsung Bioepis, a joint venture between Samsung BioLogics and Biogen, following those for Enbrel biosimilar Benepali (etanercept) and Remicade biosimilar Flixabi (infliximab), both of which have now been approved by the European Commission.